Oral CT1812 for Age-Related Macular Degeneration

Recruiting at 20 trial locations

Overseen By Theresa Devins, DrPH, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cognition Therapeutics

Disqualifiers: Wet AMD, Retinal disease, Glaucoma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, your treatment for other chronic conditions must be stable for at least 30 days before screening.

What data supports the idea that Oral CT1812 for Age-Related Macular Degeneration is an effective treatment?

The available research does not provide specific data on the effectiveness of Oral CT1812 for Age-Related Macular Degeneration. Instead, it focuses on other treatments like pegaptanib and ranibizumab, which are used for the same condition. These studies discuss outcomes and effectiveness of these alternative treatments, but there is no direct information on Oral CT1812 in the provided research. ^{1 2 3 4 5}

What safety data exists for CT1812 in treating age-related macular degeneration?

The provided research does not contain any safety data for CT1812, CT-1812, or Elayta in the treatment of age-related macular degeneration. The studies focus on other treatments such as pegaptanib and abicipar pegol, and the repurposing of other drugs for AMD. ^{1 6 7 8 9}

Is the drug CT1812 a promising treatment for age-related macular degeneration?

The drug CT1812, also known as Elayta, is considered promising for treating age-related macular degeneration because it is being actively studied in clinical trials, which suggests it has potential benefits for patients with this eye condition. ^{10 11 12 13 14}

Research Team

Anthony Caggiano

Principal Investigator

Cognition Therapeutics Inc.

Eligibility Criteria

This trial is for people over 50 with a specific eye condition called Geographic Atrophy due to dry Age-Related Macular Degeneration. Participants must have decent vision and stable health conditions. Those with recent eye surgeries, other serious eye diseases, or allergies to study drugs can't join.

Inclusion Criteria

I am 50 years old or older.

BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts

My medication for other chronic conditions has been stable for at least 30 days.

Exclusion Criteria

My vision loss is not due to dry age-related macular degeneration.

I have a retinal disease that is not dry age-related macular degeneration.

I have an eye condition that might need surgery soon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive a single daily dose of either CT1812 (200 mg) or placebo

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CT1812

Trial Overview The study tests the effectiveness of an oral drug named CT1812 against a placebo in improving this eye condition. It's a double-masked trial, meaning neither participants nor researchers know who gets the real drug or placebo during the 104-week study.

Participant Groups

Group I: CT1812 200 mg Active Control 1 Intervention

Drug: CT1812 Active Study Drug

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Cognition Therapeutics

Lead Sponsor

Trials

12

Recruited

1,100+

Findings from Research

In a study of six patients with age-related macular degeneration (AMD) treated with pegaptanib, RPE tears were identified as a potential complication, occurring in four patients within 8 weeks of the first injection.

Despite only one patient experiencing acute vision loss, three out of six patients showed significant decreases in visual acuity, highlighting the need for careful monitoring of RPE tears in patients receiving pegaptanib therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RPE tears after pegaptanib treatment in age-related macular degeneration. Chang, LK., Flaxel, CJ., Lauer, AK., et al.[2022]

The prevalence of age-related macular degeneration (AMD) in the U.S. population aged 40 and older is estimated at 1.47%, affecting approximately 1.75 million people, with a significant increase in prevalence among older age groups, particularly white women over 80 years.

The number of individuals with AMD is projected to rise by 50% to nearly 3 million by 2020, highlighting the growing public health concern as the population ages, and AMD is notably more common in white individuals compared to black individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of age-related macular degeneration in the United States. Friedman, DS., O'Colmain, BJ., Muñoz, B., et al.[2022]

In a study of 655 eyes with wet age-related macular degeneration (AMD) receiving anti-VEGF therapy, visual acuity improvements after 12 months were similar across all groups, regardless of lesion activity level, indicating that persistent lesion activity does not necessarily lead to worse visual outcomes.

The number of injections required increased slightly with more active lesions, but the overall visual improvements remained consistent, suggesting that treatment effectiveness is maintained even in cases of higher lesion activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of persistently active neovascular age-related macular degeneration treated with VEGF inhibitors: observational study data. Barthelmes, D., Walton, R., Campain, AE., et al.[2015]

In a study of 131 patients with severe neovascular age-related macular degeneration, anti-vascular endothelial growth factor therapy led to significant visual improvement, with a mean change of 0.23 logMAR at 6 months and 0.17 logMAR at 12 months.

Visual improvement was more likely in patients who received more injections and had poorer baseline visual acuity, while factors like retinal hemorrhage and subretinal fluid were associated with better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NEOVASCULAR AGE-RELATED MACULAR DEGENERATION WITH ADVANCED VISUAL LOSS TREATED WITH ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY: Clinical Outcome and Prognostic Indicators. Vogel, RN., Davis, DB., Kimura, BH., et al.[2022]

In a real-life study of 54 patients with wet age-related macular degeneration (ARMD), a treat-and-extend regimen with ranibizumab resulted in a mean visual acuity gain of 8.3 letters at 12 months and 5.2 letters at 24 months, indicating effective treatment over two years.

The study also showed significant anatomical improvements, with a mean reduction in central retinal thickness of 139.7 μm at 24 months, and a majority of patients (83.9%) either gained vision or maintained their baseline vision, demonstrating the regimen's efficacy and reduced treatment burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

24-month clinical outcomes of a treat-and-extend regimen with ranibizumab for wet age-related macular degeneration in a real life setting. Vardarinos, A., Gupta, N., Janjua, R., et al.[2018]

There is a significant need for new treatments for dry age-related macular degeneration (AMD), and repurposing existing FDA-approved drugs presents a promising strategy.

Several classes of drugs, including GPR-143 agonists, anti-diabetic medications, mitochondrial activators, and serotonin pathway drugs, are being explored for their potential to reduce AMD diagnosis, highlighting the innovative approach of using existing medications for new therapeutic purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repurposing Drugs for Treatment of Age-Related Macular Degeneration. Francisco, SG., Rowan, S.[2023]

Abicipar pegol showed comparable efficacy in improving visual acuity and reducing retinal thickness in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) in both Japan and the United States, with mean visual acuity changes of +7.8 to +8.9 letters in Japan and +4.4 to +10.1 letters in the U.S. after 16 weeks.

The treatment was generally safe, with only three cases of uveitis or vitritis reported among abicipar-treated patients, indicating a favorable safety profile for this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Patients With Neovascular Age-Related Macular Degeneration: Studies in Japan and the United States. Kunimoto, D., Ohji, M., Maturi, RK., et al.[2019]

In a study of 253 patients with neovascular age-related macular degeneration (NV-AMD) treated with pegaptanib sodium, over 90% of patients experienced less than 15 letters of vision loss after 24 and 54 weeks, which is significantly better than the 70% reported in the VISION trial.

Pegaptanib was well tolerated among patients, with no serious adverse effects such as endophthalmitis or retinal detachment reported, indicating a favorable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal pegaptanib sodium for choroidal neovascularisation secondary to age-related macular degeneration: Pan-European experience. Sivaprasad, S., Hykin, P., Saeed, A., et al.[2016]

In a study of 81 eyes from 78 patients with exudative age-related macular degeneration (AMD), both pegaptanib and ranibizumab treatments led to significant improvements in visual acuity over 12 months.

The visual outcomes for pegaptanib were found to be equivalent to those of ranibizumab, indicating that both therapies are effective options for treating small lesion size exudative AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effect between pegaptanib and ranibizumab on exudative age-related macular degeneration with small lesion size. Nishimura, Y., Taguchi, M., Nagai, T., et al.[2021]

The Clinical Age-Related Maculopathy Staging (CARMS) system is a reliable and valid tool for classifying age-related maculopathy (ARM) in clinical settings, showing substantial agreement between clinical assessments and photographic evaluations in 492 eyes of 246 participants.

The CARMS system demonstrated high sensitivity (0.83) and specificity (0.97) for advanced age-related macular degeneration, making it effective for both clinical practice and research involving ARM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the clinical age-related maculopathy staging system. Seddon, JM., Sharma, S., Adelman, RA.[2022]

In a study of 107 eyes from 88 patients with non-exudative age-related macular degeneration (neAMD) followed for at least 4 years, specific optical coherence tomography (OCT) features were identified as strong predictors of disease progression.

Drusen collapse was the most significant predictor for progression to incomplete and complete retinal pigment epithelium and outer retinal atrophy (iRORA/cRORA), while the presence of intraretinal hyporeflective spaces was the strongest predictor for conversion to neovascular AMD (nAMD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography predictors of progression of non-exudative age-related macular degeneration to advanced atrophic and exudative disease. Amarasekera, S., Samanta, A., Jhingan, M., et al.[2022]

In a study of 1616 participants, using multimodal imaging (OCT, IR, and FAF) for staging age-related macular degeneration (AMD) resulted in a more accurate prevalence assessment compared to traditional color fundus photography (CFP).

The prevalence of late AMD increased from 1.05% to 1.61% when using multimodal imaging, highlighting its importance for better estimating AMD stages, particularly for late forms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age-Related Macular Degeneration Staging by Color Fundus Photography vs. Multimodal Imaging-Epidemiological Implications (The Coimbra Eye Study-Report 6). Farinha, C., Cachulo, ML., Coimbra, R., et al.[2020]

In a post hoc analysis of the HARBOR trial involving 922 study eyes, macular neovascularization (MNV) type 3 was found to be a significant risk factor for the development of macular atrophy (MA) by month 24, with 49.2% of eyes with MNV type 3 developing new MA compared to lower rates in other MNV types.

Fellow eye MA was also identified as a predictor for new MA development, while treatment with ranibizumab did not show any association with the risk of developing MA, suggesting that the type of MNV and existing conditions in fellow eyes are more critical factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics that Correlate with Macular Atrophy in Ranibizumab-Treated Patients with Neovascular Age-Related Macular Degeneration. Staurenghi, G., Cozzi, M., Sadda, S., et al.[2023]

A study involving 2188 participants aged 70 to 95 years demonstrated that combining the Clinical Classification (CC) and the Three Continent age-related macular degeneration Consortium Severity Scale (3CACSS) into a 7-step scale improves the classification of age-related macular degeneration (AMD).

The new 7-step scale not only enhances diagnostic accuracy as AMD severity increases but also provides a clearer distinction between different stages of AMD, making it easier to identify and manage the condition effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic Risk Score Analysis Supports a Joint View of Two Classification Systems for Age-Related Macular Degeneration. Herold, JM., Zimmermann, ME., Gorski, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

RPE tears after pegaptanib treatment in age-related macular degeneration. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prevalence of age-related macular degeneration in the United States. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Outcomes of persistently active neovascular age-related macular degeneration treated with VEGF inhibitors: observational study data. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

NEOVASCULAR AGE-RELATED MACULAR DEGENERATION WITH ADVANCED VISUAL LOSS TREATED WITH ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY: Clinical Outcome and Prognostic Indicators. [2022]

5. England pubmed.ncbi.nlm.nih.gov

24-month clinical outcomes of a treat-and-extend regimen with ranibizumab for wet age-related macular degeneration in a real life setting. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Repurposing Drugs for Treatment of Age-Related Macular Degeneration. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Patients With Neovascular Age-Related Macular Degeneration: Studies in Japan and the United States. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Intravitreal pegaptanib sodium for choroidal neovascularisation secondary to age-related macular degeneration: Pan-European experience. [2016]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of the effect between pegaptanib and ranibizumab on exudative age-related macular degeneration with small lesion size. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the clinical age-related maculopathy staging system. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Optical coherence tomography predictors of progression of non-exudative age-related macular degeneration to advanced atrophic and exudative disease. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Age-Related Macular Degeneration Staging by Color Fundus Photography vs. Multimodal Imaging-Epidemiological Implications (The Coimbra Eye Study-Report 6). [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Characteristics that Correlate with Macular Atrophy in Ranibizumab-Treated Patients with Neovascular Age-Related Macular Degeneration. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Genetic Risk Score Analysis Supports a Joint View of Two Classification Systems for Age-Related Macular Degeneration. [2023]